The following data is part of a premarket notification filed by 3b Medical, Inc. with the FDA for Icodeconnect.
| Device ID | K160127 |
| 510k Number | K160127 |
| Device Name: | ICodeConnect |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | 3B MEDICAL, INC. 799 Overlook Drive Winter Haven, FL 33884 |
| Contact | Alex Lucio |
| Correspondent | Alex Lucio 3B MEDICAL, INC. 799 Overlook Drive Winter Haven, FL 33884 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-20 |
| Decision Date | 2016-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06948538362075 | K160127 | 000 |